Field of the Invention
The invention relates to the field of monitoring the integrity of pharmaceutical products which are sensitive to physical or environmental conditions. More generally, it relates to the monitoring of the integrity of perishable products. More particularly, the invention relates to ways of estimating the integrity of a pharmaceutical product as assessed from the exposure of the product to physical or environmental conditions up to at least approximately the time of its use.
Description of Related Art
The invention relates to methods and apparatuses that are used, for example, when a patient taking a medicament or a health care specialist giving the medicament to the patients wants to make sure that the medicament has not perished, in particular not perished during the time span between packaging the medicament and applying the medicament.
When it comes to sensitive or delicate goods such as pharmaceutical products or foods, it can be desirable to monitor their exposure to specific hazards such as particularly high or low temperatures, particularly high or low humidity (water-content of ambient air), or particularly strong impacts (hits, blows), so as to be able to estimate the integrity of the transported goods.
It is known to use chemical indicators for estimating the temperature exposure of a medicament. For example, a particular chemical substance is applied onto the outside of a bottle containing a fluid pharmaceutical product. If that substance is exposed to a too high or too low temperature during a too long time, its color is (visibly) changed. Corresponding products are commercially available.
Furthermore, RFID tags are frequently used by transport and logistics companies for monitoring the integrity of various goods during their transport from the manufacturer of the goods to a distributor or wholesaler. Such RFID tags are, e.g., attached to a trading unit on a palette, and results of measurements carried out in the RFID tag, e.g., temperature measurements, are wirelessly transmitted to the RFID reader in order to be evaluated and/or looked at then.
One object of the invention is to create a new way of enabling a person (finally) using a perishable product such as a pharmaceutical product, to check whether or not the product is—with a high probability—sound (flawless), in particular at (approximately) the time of using it.
Another object of the invention is to provide a simple way of enabling a person to check the integrity of a perishable product, in particular approximately at the time of its use.
Another object of the invention is to provide a cost-efficient way of enabling a person to check the integrity of a perishable product, in particular approximately at the time of its use.
Another object of the invention is to provide a way of enabling a person to check the integrity of a perishable product, in particular approximately at the time of its use, which is compatible with already established packaging and distribution schemes.
Another object of the invention is to provide a way of enabling a person to check the integrity of a perishable product without requiring the presence of any additional object for doing so, e.g., without a reading device.
Another object of the invention is to provide a way of minimizing the probability of fraud or deceit when it comes to prove or demonstrate an integrity status of a perishable, in particular pharmaceutical, product approximately at the time of its use.
Another object of the invention is to provide ways for preventing or reducing malpractice in conjunction with monitoring the integrity of sensitive products.
A corresponding retail package and a corresponding retail unit shall be provided, as well as a method for monitoring an integrity of a perishable product. And in addition, an electronic tag for obtaining information relating to the integrity of a product as assessed from an exposure of said product to physical or environmental conditions during a time span shall be provided and a method for manufacturing a retail unit.
Further objects emerge from the description and embodiments below.
The retail package for a perishable product comprises                a box as an outer package;        an electronic tag for obtaining information relating to the integrity of the product as assessed from an exposure of said product to physical or environmental conditions during a time span;wherein said tag comprises        a main part comprising an electronics unit;        a rip strip comprising a breakable electrical connection operationally connected to said electronics unit.        
Said electronics unit comprises                a control unit;        a sensor unit comprising at least one sensor for monitoring said physical or environmental conditions;        a display unit comprising a display for displaying data relating to said integrity referred to as status data;        a switch.        
And said control unit is structured and configured for                detecting a breaking of said electrical connection;        terminating said monitoring in reaction to said detecting said breaking of said electrical connection; and for        effecting that said display unit displays said status data in reaction to an operation of said switch.        
Such a retail package can be very compact and cost-efficient. And it can make possible that a user who wants to use or apply the product (who usually is not a person trading it or dealing with it), such as, in case of a medical product, a patient or a health care specialist, can in a simple and direct way and without further education and without needing further equipment or tools operate the tag and find out about the integrity of the product, in particular at (approximately) the time of using or applying the product.
The term “retail package” is used in order to distinguish the package from wholesale packages or bundles. The latter comprise high numbers of retail packages and do not reach a user of the product. The retail package usually is the lowest package level to be sold (under normal circumstances). Inside said box, there is usually no further box present, in particular not a (further) cardboard box, more particularly not a (further) folding carton. However, the product usually is contained in a container, the container being inside the box. In case of pharmaceutical products, the box usually also contains a package insert, which usually is one piece of paper explaining details concerning the product, such as its composition, its effects and adverse reactions and dosage instructions. A retail package may contain one or more doses of the product. And it may be a package for patients or for clinics.
As is usually the case for tags for integrity monitoring, it is assumed that said perishable product is exposed to approximately the same physical or environmental conditions as is the tag.
The time span usually is a time span during which the product is stored or transported.
The switch usually is a user-operable switch. Suitable switches can be, e.g., electro-mechanical switches or capacitive switches.
It is usually provided that when the rip strip is ripped (in a suitable place), the electrical connection is broken, e.g., because one or more conductor lines (in particular a conductor line loop) of the rip strip is interrupted. This can be detected by the control unit, e.g., by sensing an increase of an ohmic resistance. It may be an indication of an end of the time span, and thus, the monitoring can be terminated in reaction thereto.
The rip strip usually is a flat member (its extension in a first dimension being clearly smaller than in the other two) and has an elongated shape (its extension in a second dimension being smaller than in the third dimension). The breaking said electrical connection usually takes place by dividing (cutting, tearing apart) the rip strip generally along the second dimension.
The display usually is a visual display.
Displaying the status data in reaction to an operation of the switch is effected at least after the end of the time span. This can make possible to review the integrity status the product had when the box was opened and/or when the product was accessed and/or when the product was applied. It may, however be provided that displaying the status data in reaction to an operation of the switch is also effected already before the end of the time span. This can make possible early checks of the product integrity.
In any event, the display does usually not permanently display the status data. This saves energy and thus makes possible a long operation duration of the tag and thus a long shelf life of the retail package and of the retail unit.
Furthermore, it can be provided that displaying the status data takes place only in reaction to operating the switch. However, it may also be provided that it takes place also in reaction to terminating the monitoring and thus at the end of the time span and thus usually when the breakable electrical connection is broken. And alternatively or additionally thereto, it may be provided that displaying the status data takes place periodically, e.g., in regular time intervals, the (pause) interval typically being between 1 second and 2 minutes, in particular between 5 seconds and 30 seconds. Such an “automatic” display of the status data may take place after the end of the time span only or during the time span only or both, i.e. from the beginning of the time span. Looking at the display in the right moment (or waiting for up to one the pause interval) may thus dispense with operating the switch when the integrity status shall be checked.
In one embodiment, said perishable product is a pharmaceutical product. The pharmaceutical product can be, e.g., a synthetic pharmaceutically active substance, a natural pharmaceutically active substance, a vaccine. Pharmaceutical products are often provided in form of tablets, capsules, powder, liquids, emulsions.
In another embodiment, the perishable product is perishable food, a food product.
In another embodiment, said perishable product is perishable chemical sub stance.
In one embodiment which may be combined with one or more of the before-mentioned embodiments, the main part is attached to the box. In particular, the main part can be attached to an inside of the box. But attaching the main part to the outside of the box is possible, too.
In an alternative embodiment, the main part is attached to a card present inside the box.
Attaching the main part (to the box or to the card) can be accomplished by, e.g, bonding, gluing, using a fluidly applicable glue, using a double-faced adhesive tape, using a polymer cover foil sandwiching the main unit between itself and the box and including a circumferential portion surrounding the main part, which is bonded to the box, or in another way.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the box is a cardboard box, more particularly a folding carton.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the rip strip is attached to the box. It may, in particular be provided that the rip strip is attached to an inside of the box. But attaching the rip strip to the outside of the box is possible, too. And the rip strip may, in one region of the rip strip, be attached to an inside of the box and, in addition, in another region of the rip strip, be attached to an outside of the box.
In an alternative embodiment, the rip strip is attached to a card present inside the box. That card may be (and usually is) identical with the above-mentioned card to which the main part of the tag may be attached.
Attaching the rip strip (to the box or to the card) can be accomplished by, e.g, bonding, gluing, using a fluidly applicable glue, using a double-faced adhesive tape. The attaching may be accomplished in one or more regions of the rip strip, in particular over a major portion of a face of the rip strip.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the rip strip is attached to the box, and the box is designed to have one or more opening sides at which the box can be opened in order to access the product when the product is present inside the box, and the rip strip is attached to the box in such a way that the electrical connection is broken when the box is opened at one of the opening sides. This may constitute a security feature. It may in particular be provided that the box is designed to have exactly one opening side (i.e. no more and no less than one opening side). This facilitates the application of the rip strip. For example, in case the box is an otherwise conventional folding carton, one original opening side can be sealed, e.g., by gluing the (tongue-like) flap to an inner surface of the folding carton, and the oppositely arranged opening side remains as the only opening side. But it may also be provided that the box is designed to have exactly two opening sides (i.e. no more and no less than two opening sides). This allows, at least in case the box is a conventional folding carton, to dispense with additional manufacturing steps for sealing one of the opening sides.
Opening the box may in particular include moving a portion of the box versus another portion of the box, in particular it may include, e.g., when the box is a folding carton, pulling a (tongue-like) flap of the box out of the box, the flap forming a tongue of a side part of the box, the flap sitting next to another side part of the box when the box is closed.
A possible alternative to the above embodiment (in which a link between opening the box and ripping the rip strip is enforced in the described way) is to provide with the box, in particular inside the box, a card unit, the card unit including the tag and a card, e.g., a card made of cardboard or a polymer-based card. The tag will usually be attached to the card, either the main part only or the rip strip only or, rather, both.
On the card, a textual and/or graphical description indicating to break the connection when opening the box and/or indicating to break the connection when accessing the product and/or indicating to break the connection when using or applying the product may be provided. This can facilitate the handling of the retail package. The textual and/or graphical description may additionally or alternatively be present on the box (in particular printed thereon).
In one embodiment which may be combined with one or more of the before-mentioned embodiments, the rip strip comprises or essentially is a printed circuit board (PCB). It may, in particular, include or essentially be a flexible printed circuit board. And, more particularly, it may include or essentially be a foil in and/or on which at least one conductor line is present which is operationally connected to the electronics unit. The at least one conductor line forms the breakable electrical connection and it may, in particular, describe a loop. The foil may, in particular, be an electrically insulating polymer foil. The (usually flexible, but possibly rigid) printed circuit board is operationally connected to the electronics unit, more particularly one or more conductor lines of the (flexible) printed circuit board are. The rip strip and the electronics unit may share one and the same printed circuit board; the PCB of the rip strip may be continuous with a PCB of the electronics unit.
It may be provided that the rip strip comprises a foil and, present on the foil, at least one conductor line operationally connected to the electronics unit. In particular, the at least one conductor line may form at least one loop. Typically one or two loops, perhaps three are provided. Each loop may constitute one breakable electrical connection. In case of a single loop, the interruption thereof usually will indicate that the product is about to be accessed and/or indicate that the end of the time span has come (and the monitoring is terminated). In case of two loops, the first is like the before-described single one, and the interruption of the second loop usually will indicate that the product is about to be packaged in the box (or has just been packaged in the box) and/or indicate the beginning of the time span (and thus the start of the monitoring). In case of three loops, yet another functionality may be added to those of the before-described ones.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the display unit is structured and configured for displaying the status data by flashing. In other words, the status data are encoded in flashing.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the display unit includes one or more light emitters for emitting light pulses, and wherein the data is encoded in a sequence of light pulses emitted by the one or more light emitters. This can allow to realize the tag and thus also the retail package in a particularly small and particularly cost-efficient way, and it may simplify the manufacture of the tag. The data may more particularly be encoded in one or more of
the color of the light pulses;
a duration of the light pulses;
the number of the light pulses in the sequence.
The light emitters may, in particular, be light emitters for selectively emitting light of at least two different colors. For example, a light source for emitting green light and a light source for emitting red light may be provided.
The light emitters may be, e.g., LEDs (light emitting diodes). LEDs have a low power consumption, which can contribute to a long operating duration of the tag.
Usually, the tag includes merely exactly one display (and not an additional one).
In view of the above-described (and below-described) ways of realizing the display, it is possible to provide that the display is a not-graphical display, at least in the sense that a graphical display would allow to visualize a plurality of different shapes (such as shapes symbolizing letters and/or numbers).
Providing a display of the above-described kind may allow to dispense with graphical displays, at least in the sense that a graphical display would allow to visualize a plurality of different shapes (such as shapes symbolizing letters and/or numbers).
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the display automatically displays the status data periodically. The displaying may take place, e.g., in intervals of at least 1 second, more particularly of at least 5 seconds, and/or of at most 2 minutes, more particularly of at most 40 seconds. This may make dealing with the retail package easier, but usually at the expense of battery power.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the box has a transparent portion (or window), and the tag is attached inside the box such that the display is visible through transparent portion (from the outside). This may make possible to prevent tampering with the tag (at least tampering without opening the box), while allowing to see the display. Access to the switch, so as to allow operating the switch (without opening the box) may be provided, e.g., by operating the switch through the window.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the control unit is structured and configured for receiving data or signals from the sensor unit, the data or signals being indicative of currently present physical or environmental conditions, and for obtaining the status data from these data or signals. In order to accomplish the latter, the status data are usually obtained in dependence of predescribed limitations for the exposure of the product to the physical or environmental conditions. Those predescribed limitations are usually stored in the tag, in the electronics unit, in form of corresponding data. For example, the control unit usually will compare the current conditions to threshold values such as a value that shall never be exceeded and/or a value that shall never be fallen short of and/or a value that may be exceeded (or fallen short of) for only less than a prescribed time duration. If an alarm condition is met because of extreme values (or extreme values during a too long time duration), it must be assumed that the integrity of the product is not present anymore, i.e. that the product is not in sound condition anymore. This fact can be indicated by the display of the tag, wherein it is possible to provide that different types of alarm conditions are indicated by the display in different ways.
Accordingly, the status data are usually indicative of events (in particular failures) that have occurred after an initial point in time, namely after the moment when the integrity monitoring has started, i.e. after the beginning of the time span. Status data usually reflect only events (in particular failures) that have occurred during the time span. A failure usually is a deviation from or transgression of the above-mentioned predescribed limitations, e.g., an exceeding of a threshold value.
In one embodiment referring to the before-mentioned embodiment, data representative of the predescribed limitations are programmable. Usually, such data are stored in the electronics unit, and in case they are programmable, there is no limitation to one (i.e. to a single) set of such data. This can make possible to use one and the same tag for different products of different sensitivity to the physical or environmental conditions. Thus, it can be sufficient to store only tags of a single type for many different products instead of one type of tag for each type of product.
In one embodiment referring to the before-mentioned embodiment, the rip strip includes at least two contact pads (providing electrical contacts), which are operationally (usually electrically and more particularly galvanically) connected to the electronics unit, and the data representative of the predescribed limitations are programmable by means of signals (usually digital signals) applied to the contact pads. In a first possibility, it can be provided that one of a plurality of sets of such data representative of the predescribed limitations are selectable by the applied signals. Those sets of data (including at least one value each, such as a maximally allowed temperature) are in this case usually stored in the electronics unit, such that sufficient memory space for the plurality of data sets is required in the electronics unit. However, programming may be accomplished rather rapidly this way. For example, if a specific type of tag shall be used for monitoring one of various, e.g., twenty, different products (in particular pharmaceutical products), each having different prescribed limitations, a corresponding number of sets of, e.g., threshold temperatures (and possibly also time durations) may be stored in the electronics unit, and when a specific product shall be monitored, the signals applied to the contact pads allow to select the suitable set of data, such that these are applied in the subsequent monitoring. In a second possibility, the data representative of the predescribed limitations are entered into the electronics unit by applying the signals. This provides additional flexibility and requires only relatively little storage space in the electronics unit. The programming, however, may be more time consuming than in case of the first possibility. Referring again to the contact pads, it can be provided that these are arranged in such a location of the rip strip that they are removed from the tag when the rip strip is ripped for indicating that the monitoring shall start, i.e. for indicating the beginning of the time span. As has been described further above, a first and a second loop may be provided, a detection of an interruption of the second loop indicating the beginning of the time span. The contact pads may thus in particular be located, with respect to a coordinate from the main part of the tag along the extension of the rip strip (which usually is a coordinate along the direction of the largest extension of the rip strip), at a location beyond the location of that portion of the second loop which is located farthest along the coordinate. A ripping of the rip strip along a direction approximately perpendicular to the coordinate by which the second loop is opened (interrupted) will thus usually also result in a cutting off of the contact pads from the tag. Attempts to try to program the tag (more particularly to program data representative of the predescribed limitations) after monitoring has started can be impeded this way.
It is to be noted that, generally, it would also be possible, as an alternative or as an addition to the described programming tags, to provide a contactless programming, e.g., via electromagnetic radiation. This might, with respect to the above-described provision of contact pads for programming, result in a faster programming (programming possibly taking place simultaneously with other process steps during packaging) and in higher tag manufacturing costs and possibly also in larger outer dimensions of the tag, more particularly of the main part of the tag.
Status data displayed after the monitoring (measuring, sensing) has been terminated, i.e. after the end of the time span may be referred to as “final” status data. In that case, all alarms may be indicated that occurred between the initial point in time at which monitoring began and the time of termination of the monitoring. It is furthermore possible to provide that these “final” status data are also displayed (even without operating the switch) when the monitoring is terminated. This makes possible an immediate check of the integrity status. And a calculation and/or a storing step may also take place at that time, so as to obtain these “final” status data and store them in the tag, so as to readily have access to them later on.
If it is provided that status data may be displayed by the display already during the time span, e.g., in reaction to operating the switch, these status data certainly merely reflect those alarm conditions which were met up to that instant.
Furthermore, it is also possible to provide that in addition to displaying status data by means of the display (or as an alternative thereto), status data can be transmitted by the tag via electro-magnetic radiation in the radio-frequency (RF) range (radio-frequency radiation).
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the tag, in particular the electronics unit, includes an RF receiver and an RF transmitter, or an RF transceiver, and the control unit is structured and configured for effecting that the status data are transmitted using the RF transmitter or the RF transceiver. This transmission of status data may be effected in reaction to an operation of the switch and/or in reaction to receiving, in the tag, a corresponding request signal by means of the RF receiver or RF transceiver. An RF reading device may, this way, receive status data from the tag, in a contact-less fashion. This may be of advantage when a large number of syringes shall be examined with respect to their individual product integrity.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the tag includes no RFID (Radio Frequency Identification) responding capability. However, it is, as an alternative also possible to provide that the tag includes RFID responding capability.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments except for the last-mentioned one, the tag includes RFID (Radio Frequency Identification) responding capability. For example, the tag (in particular the electronics unit) includes an RF receiver and an RF transmitter, or an RF transceiver. This may allow to identify in a contactless fashion, each individual tag and thus each individual retail package (or retail unit, cf. below). In this case, each tag may be provided with a unique identifier, which typically would be stored in the electronics unit, and which can be transmitted by the tag via RF, e.g., to an RFID reader. This may allow to achieve a quick overview over a large number of retail packages (or retail units, cf. below), e.g., in order to check which retail packages (or retail units, cf. below) are present (and thus, which retail packages or retail units, cf. below, would possibly be missing).
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the physical or environmental conditions include a temperature, in particular an ambient temperature.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the physical or environmental conditions include a pressure, in particular an ambient pressure.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the physical or environmental conditions include a humidity, in particular a relative humidity (water content) of the (ambient) air.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the physical or environmental conditions include an acceleration.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the sensor unit (and/or the control unit) is structured and configured for measuring the physical or environmental conditions at various times during the time span, in particular in regular intervals.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the main part includes a housing, e.g., made of a polymer, containing the electronics unit. In particular, the housing has an opening through which the electronics unit can be pushed into the housing.
In one embodiment, which may be combined with one or more of the before-mentioned embodiments, the electronics unit includes a battery, usually for powering other constituents of the electronics unit.
The retail unit includes a retail package of any of the described kinds and further includes the perishable product.
In one retail unit embodiment, the retail unit is a pharmaceutical retail unit, and the perishable product is a pharmaceutical product. However, other perishable or delicate products are, more generally, also contemplated, such as food products or chemical products.
In one embodiment, which may be combined with the last-mentioned embodiment, the retail unit includes one or more containers containing the product. Such a container may be an enclosure for the product. Typical containers, at least for pharmaceutical products, are blister packages, vials, tubes, flacons, vessels, bags such as polymer foil bags.
In one embodiment, which may be combined with one or more of the before-mentioned retail unit embodiments, the main part is attached to the container—as an alternative to being attached to the box or to the card.
In one embodiment, which may be combined with one or more of the before-mentioned retail unit embodiments, the rip strip is attached to the container. This may be provided alternatively or in addition to having the rip strip attached to the box or to the card.
The invention includes retail units with features of corresponding retail packages according to the invention, and, vice versa, also retail packages with features of corresponding retail units according to the invention.
The advantages of the retail units basically correspond to the advantages of corresponding retail packages, and, vice versa, the advantages of the retail packages basically correspond to the advantages of corresponding retail units.
The method for monitoring an integrity of a perishable product includes the steps of                providing an electronic tag; and        providing a box as an outer package for the perishable product;        wherein the tag is a tag for obtaining information relating to the integrity of the product as assessed from an exposure of the product to physical or environmental conditions during a time span, wherein the tag comprises        a main part comprising an electronics unit;        a rip strip comprising a breakable electrical connection operationally connected to the electronics unit.        
And the electronics unit includes                a control unit;        a sensor unit having at least one sensor for monitoring the physical or environmental conditions;        a display unit having a display for displaying data relating to the integrity referred to as status data;        a switch.        
And the control unit is structured and configured for                detecting a breaking of the electrical connection;        terminating the monitoring in reaction to the detecting the breaking of the electrical connection; and for        effecting that the display unit displays the status data in reaction to an operation of the switch.        
In one method embodiment, the method includes the step of bonding the main part to the box. Therein, it may in particular be bonded to a face of a side part of the box, the face facing the inside of the box when the box is closed (“inside of box”). Alternatively, the method may include the step of bonding the main part to a container containing the product. And in another alternative, the method includes the step of bonding the main part to a card present in the box.
In one method embodiment, which may be combined with the before-mentioned method embodiment, the method comprises the step of bonding at least a portion of the rip strip to the box. Therein, it may in particular be bonded to a face of a side part of the box, which face faces the inside of the box when the box is closed.
In one method embodiment, which may be combined with one or more of the before-mentioned method embodiments, the method includes the step of bonding at least a portion of the rip strip to a container containing the product. Note that it is possible to provide that one portion of the rip strip may be bonded to the box and another portion of the rip strip is bonded to the container.
In one method embodiment, which may be combined with one or more of the before-mentioned method embodiments, the method includes the step of ripping the rip strip. The ripping of the rip strip may be accomplished for terminating the integrity monitoring (and ending the time span).
In one method embodiment, which may be combined with one or more of the before-mentioned method embodiments, the method includes the step of operating the switch. Operating the switch may be accomplished for requesting a displaying of the status data.
In one method embodiment, which may be combined with one or more of the before-mentioned method embodiments, the tag includes at least one sensor for sensing the physical or environmental conditions, the method including the step of                by means of the sensor, creating data or signals representative of the physical or environmental conditions at various times during the time span.        
In one method embodiment, which may be combined with one or more of the before-mentioned method embodiments, the method includes the step of inserting the product into the box and closing the box.
The invention includes monitoring methods with features of corresponding retail packages or retail units according to the invention, and, vice versa, also retail packages and retail units with features of corresponding monitoring methods according to the invention.
The advantages of the monitoring methods basically correspond to the advantages of corresponding retail packages or retail units, and, vice versa, the advantages of the retail packages and retail units basically correspond to the advantages of corresponding monitoring methods.
The method for manufacturing a retail unit including a perishable product include the steps of                a) providing the product;        b) providing an unfolded folding carton;        c) folding the folding carton;        d) inserting the product into the folded folding carton;        e) providing an electronic tag for obtaining information relating to the integrity of the product as assessed from an exposure of the product to physical or environmental conditions during a time span, the tag comprising a main portion and a rip strip;        f) attaching the tag to the folding carton.        
The tag includes                the main part having an electronics unit;        the rip strip having a breakable electrical connection operationally connected to the electronics unit;        
and the electronics unit includes                a control unit;        a sensor unit having at least one sensor for monitoring the physical or environmental conditions;        a display unit having a display for displaying data relating to the integrity referred to as status data;        a switch;        
wherein the control unit is structured and configured for                detecting a breaking of the electrical connection;        terminating the monitoring in reaction to the detecting the breaking of the electrical connection; and for        effecting that the display unit displays the status data in reaction to an operation of the switch.        
The method further includes the step of                g) starting monitoring the exposure of the product to the physical or environmental conditions by manipulating a part of the tag, in particular by breaking another electrical connection, more particularly by ripping the rip strip.        
It is to be noted that the method steps do not necessarily need to be carried out in the cited order. For example, it is possible to carry out step f) before carrying out step c); and step g) may be carried out before carrying out step c) and/or before carrying out step f); and step d) may be carried out after step f) and/or after step g).
In step d), the product may be contained in one or more containers, the container(s) being inserted into the folded folding carton in step d).
Alternatively to step g), the following step g′) may be carried out:                g′) starting monitoring the exposure of the product to the physical or environmental conditions by operating an initiating switch of the tag, wherein the initiating switch is identical with or different from the before-mentioned switch.        
Further details concerning possible initiating switches are described further below.
The invention includes manufacturing methods with features of corresponding retail packages or retail units or monitoring methods according to the invention, and, vice versa, also retail packages and retail units and monitoring methods with features of corresponding manufacturing methods according to the invention. For example, the bonding steps described for the monitoring methods may also be provided in the manufacturing methods. And, e.g., step g) or step g′) described for the manufacturing methods, may also be provided in the monitoring methods.
The advantages of the manufacturing methods basically correspond to the advantages of corresponding retail packages or retail units or monitoring methods, and, vice versa, the advantages of the retail packages and retail units and/or monitoring methods basically correspond to the advantages of corresponding manufacturing methods.
The electronic tag for obtaining information relating to the integrity of a product as assessed from an exposure of the product to physical or environmental conditions during a time span includes:                a main part including an electronics unit;        a rip strip including a breakable electrical connection operationally connected to the electronics unit;        
wherein the electronics unit includes:                a control unit;        a sensor unit including at least one sensor for monitoring the physical or environmental conditions;        a display unit including a display for displaying data relating to the integrity referred to as status data;        a switch.        
And the control unit is structured and configured for                detecting a breaking of the electrical connection;        terminating the monitoring in reaction to the detecting the breaking of the electrical connection; and for        effecting that the display unit displays the status data in reaction to an operation of the switch.        
The invention includes tags with features of corresponding retail packages or retail units or methods according to the invention, and, vice versa, also retail packages and retail units and methods with features of corresponding tags according to the invention.
The advantages of the tags basically correspond to the advantages of corresponding retail packages or retail units or methods, and, vice versa, the advantages of the retail packages and retail units and methods basically correspond to the advantages of corresponding tags.
In a specific view upon the invention, the switch is dispensed with and, accordingly, also the property of the control unit to be structured and configured for effecting that the display unit displays the status data in reaction to an operation of the switch is dispensed with and is, moreover, replaced by a functionality (provided by the control unit) that the “final” status data are displayed (for some time duration such as between 1 second and 1 minute) when the monitoring is terminated.
Thus, in that first particular aspect of the invention, the retail package for a perishable product includes                a box as an outer package;        an electronic tag for obtaining information relating to the integrity of the product as assessed from an exposure of the product to physical or environmental conditions during a time span;        
wherein the tag includes                a main part comprising an electronics unit;        a rip strip comprising a breakable electrical connection operationally connected to the electronics unit.        
The electronics unit includes                a control unit;        a sensor unit having at least one sensor for monitoring the physical or environmental conditions; and        a display unit having a display for displaying data relating to the integrity referred to as status data.        
And the control unit is structured and configured for
detecting a breaking of the electrical connection;
and for
terminating the monitoring; and
effecting that the display unit displays the status data;
in reaction to the detecting the breaking of the electrical connection.
The methods, the retail unit and the tag in this first particular aspect have, of course, corresponding features.
This makes possible an immediate check of the integrity status when terminating the monitoring, and the tag can be even smaller an less costly due to not having to provide a switch.
Of course, the other features and embodiments described above or below in the present patent application compatible with this first particular aspect of the invention may also be applied to or combined with this first particular aspect of the invention.
In particular, it may be provided also in this aspect, that a calculation and/or a storing step takes place at the time of terminating the monitoring (in reaction to the detecting the breaking of the electrical connection), so as to obtain the “final” status data and store them in the tag, so as to readily have access to them later on.
And also, it may be provided that displaying the status data takes place periodically, e.g., in regular time intervals.
In another specific view upon the invention, the rip strip is dispensed with—at least in its function as a means for effecting a terminating of the monitoring—and, accordingly, also the property of the control unit to be structured and configured for detecting a breaking of the electrical connection and for terminating the monitoring in reaction to the detecting the breaking of the electrical connection is dispensed with and is, moreover, replaced by a functionality (provided by the control unit) that the monitoring is terminated in reaction to an operation of a switch we shall refer to as terminating switch. That terminating switch may be identical with or different from the switch (“display switch”) for effecting the displaying of the status data (if present). If the switches are identical, different effects may be provoked by differently operating the switch. For example, a brief operation of the switch (e.g., for at most 1 or 1.5 seconds) provokes a displaying of the status data, whereas a longer operation (e.g., for more than 8 seconds) effects a termination of the monitoring.
Thus, in that second particular aspect of the invention, the retail package for a perishable product includes                a box as an outer package;        an electronic tag for obtaining information relating to the integrity of the product as assessed from an exposure of the product to physical or environmental conditions during a time span;wherein the tag includes a main part having an electronics unit.        
The electronics unit includes                a control unit;        a sensor unit including at least one sensor for monitoring the physical or environmental conditions;        a display unit including a display for displaying data relating to the integrity referred to as status data;        a display switch and a terminating switch, wherein the display switch and the terminating switch are identical or are different from each other.        
And the control unit is structured and configured for                terminating the monitoring in reaction to an operation of the terminating switch; and for        effecting that the display unit displays the status data in reaction to an operation of the display switch.        
The methods, the retail unit and the tag in this second particular aspect have, of course, corresponding features.
This provides an alternative way of terminating the monitoring, and the monitoring may be terminated in a contact-less manner, e.g., when a magnetic or an inductive terminating switch is used and also in case of a capacitive switch.
Of course, the other features and embodiments described above or below in the present patent application compatible with this second particular aspect of the invention may also be applied to or combined with this second particular aspect of the invention.
It is furthermore, in yet another aspect of the invention, possible to provide a single switch that fulfills at least three different functions accessible by differently operating the switch. These functions may in particular be: starting the monitoring; terminating the monitoring; requesting a displaying of the status data (usually during the whole time span and thereafter, too, namely then displaying the “final” status data). The different ways of operating may be operating the switch for time durations in different non-overlapping time intervals. For example, operating the switch for less than 2 seconds is interpreted by the control unit as a request for displaying status data, operating the switch for a duration between 3 and 6 seconds is interpreted by the control unit as a request for starting the time span (and thus the monitoring), and operating the switch for more than 9 seconds is interpreted by the control unit as a request for ending the time span and thus terminating the monitoring.